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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K936193
Device Name COMB-18 WOUND DRESSING
Applicant
Vsc Health Care Products
P.O. Box 710
Parkman,  OH  44080
Applicant Contact OWEN M GRANT, SR.
Correspondent
Vsc Health Care Products
P.O. Box 710
Parkman,  OH  44080
Correspondent Contact OWEN M GRANT, SR.
Regulation Number880.5090
Classification Product Code
KMF  
Date Received12/27/1993
Decision Date 04/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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